Chaotropic salts in liquid chromatographic method development for the determination of pramipexole and its impurities following quality-by-design principles
Samo za registrovane korisnike
2015
Članak u časopisu (Objavljena verzija)
Metapodaci
Prikaz svih podataka o dokumentuApstrakt
The aim of this paper is to present a development of liquid chromatographic method when chaotropic salts are used as mobile phase additives following the QbD principles. The effect of critical process parameters (column chemistry, salt nature and concentration, acetonitrile content and column temperature) on the critical quality attributes (retention of the first and last eluting peak and separation of the critical peak pairs) was studied applying the design of experiments-design space methodology (DoE-DS). D-optimal design is chosen in order to simultaneously examine both categorical and numerical factors in minimal number of experiments. Two ways for the achievement of quality assurance were performed and compared. Namely, the uncertainty originating from the models was assessed by Monte Carlo simulations propagating the error equal to the variance of the model residuals and propagating the error originating from the model coefficients' calculation. The baseline separation of pramipe...xole and its five impurities is achieved fulfilling all the required criteria while the method validation proved its reliability.
Ključne reči:
Chaotropic salts / Quality-by-design / Design space / Liquid chromatography / PramipexoleIzvor:
Journal of Pharmaceutical and Biomedical Analysis, 2015, 102, 314-320Izdavač:
- Elsevier Science BV, Amsterdam
Finansiranje / projekti:
- Modelovanje različitih hromatografskih sistema sa hemometrijskim pristupom u farmaceutskoj analizi (RS-MESTD-Basic Research (BR or ON)-172052)
DOI: 10.1016/j.jpba.2014.09.031
ISSN: 0731-7085
PubMed: 25459929
WoS: 000347277500039
Scopus: 2-s2.0-84908428492
Institucija/grupa
PharmacyTY - JOUR AU - Vemić, Ana AU - Rakić, Tijana AU - Malenović, Anđelija AU - Medenica, Mirjana PY - 2015 UR - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2379 AB - The aim of this paper is to present a development of liquid chromatographic method when chaotropic salts are used as mobile phase additives following the QbD principles. The effect of critical process parameters (column chemistry, salt nature and concentration, acetonitrile content and column temperature) on the critical quality attributes (retention of the first and last eluting peak and separation of the critical peak pairs) was studied applying the design of experiments-design space methodology (DoE-DS). D-optimal design is chosen in order to simultaneously examine both categorical and numerical factors in minimal number of experiments. Two ways for the achievement of quality assurance were performed and compared. Namely, the uncertainty originating from the models was assessed by Monte Carlo simulations propagating the error equal to the variance of the model residuals and propagating the error originating from the model coefficients' calculation. The baseline separation of pramipexole and its five impurities is achieved fulfilling all the required criteria while the method validation proved its reliability. PB - Elsevier Science BV, Amsterdam T2 - Journal of Pharmaceutical and Biomedical Analysis T1 - Chaotropic salts in liquid chromatographic method development for the determination of pramipexole and its impurities following quality-by-design principles VL - 102 SP - 314 EP - 320 DO - 10.1016/j.jpba.2014.09.031 ER -
@article{ author = "Vemić, Ana and Rakić, Tijana and Malenović, Anđelija and Medenica, Mirjana", year = "2015", abstract = "The aim of this paper is to present a development of liquid chromatographic method when chaotropic salts are used as mobile phase additives following the QbD principles. The effect of critical process parameters (column chemistry, salt nature and concentration, acetonitrile content and column temperature) on the critical quality attributes (retention of the first and last eluting peak and separation of the critical peak pairs) was studied applying the design of experiments-design space methodology (DoE-DS). D-optimal design is chosen in order to simultaneously examine both categorical and numerical factors in minimal number of experiments. Two ways for the achievement of quality assurance were performed and compared. Namely, the uncertainty originating from the models was assessed by Monte Carlo simulations propagating the error equal to the variance of the model residuals and propagating the error originating from the model coefficients' calculation. The baseline separation of pramipexole and its five impurities is achieved fulfilling all the required criteria while the method validation proved its reliability.", publisher = "Elsevier Science BV, Amsterdam", journal = "Journal of Pharmaceutical and Biomedical Analysis", title = "Chaotropic salts in liquid chromatographic method development for the determination of pramipexole and its impurities following quality-by-design principles", volume = "102", pages = "314-320", doi = "10.1016/j.jpba.2014.09.031" }
Vemić, A., Rakić, T., Malenović, A.,& Medenica, M.. (2015). Chaotropic salts in liquid chromatographic method development for the determination of pramipexole and its impurities following quality-by-design principles. in Journal of Pharmaceutical and Biomedical Analysis Elsevier Science BV, Amsterdam., 102, 314-320. https://doi.org/10.1016/j.jpba.2014.09.031
Vemić A, Rakić T, Malenović A, Medenica M. Chaotropic salts in liquid chromatographic method development for the determination of pramipexole and its impurities following quality-by-design principles. in Journal of Pharmaceutical and Biomedical Analysis. 2015;102:314-320. doi:10.1016/j.jpba.2014.09.031 .
Vemić, Ana, Rakić, Tijana, Malenović, Anđelija, Medenica, Mirjana, "Chaotropic salts in liquid chromatographic method development for the determination of pramipexole and its impurities following quality-by-design principles" in Journal of Pharmaceutical and Biomedical Analysis, 102 (2015):314-320, https://doi.org/10.1016/j.jpba.2014.09.031 . .